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Alendronate gastric ulcers.

D Y Graham1, H M Malaty

  • 1Department of Medicine, Veterans Affairs Medical Center, Houston, TX 77030, USA. dgraham@bcm.tmc.edu

Alimentary Pharmacology & Therapeutics
|April 24, 1999
PubMed
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The 10 mg dose of alendronate, commonly used for osteoporosis, can cause gastric ulcers and significant mucosal injury. This finding suggests potential gastrointestinal risks associated with alendronate use.

Area of Science:

  • Gastroenterology
  • Pharmacology
  • Bone Metabolism

Background:

  • Alendronate (Fosamax) is prescribed for metabolic bone diseases.
  • Higher doses of alendronate have previously been shown to cause gastric damage.
  • The standard dose for osteoporosis is 10 mg daily.

Purpose of the Study:

  • To determine if the 10 mg daily dose of alendronate induces gastric ulcers.
  • To assess alendronate's impact on esophageal and duodenal mucosa.

Main Methods:

  • A randomized, endoscopist-blind, crossover study compared 10 mg alendronate daily to placebo.
  • Participants were healthy volunteers aged 40 years or older.
  • Video-endoscopy evaluated mucosal damage after 7 and 14 days.

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Main Results:

  • Gastric mucosal damage occurred in 38% of alendronate recipients versus 13% on placebo.
  • Six subjects on alendronate experienced clinically significant gastric injury, including two ulcers.
  • No duodenal injury was observed; one participant had esophageal erosions.

Conclusions:

  • Alendronate at the 10 mg dose can cause gastric ulceration.
  • Alendronate use may be linked to upper gastrointestinal bleeding complications.
  • Post-marketing surveillance is recommended to monitor gastrointestinal side effects.